Otowave 202 Portable Tympanometer— 510(k) K150163

Name: FDA 510(k) clearance K150163
Creator: U.S. Food and Drug Administration
Published: 2015-04-23

Substantially Equivalent

Amplivox, Ltd.

FDA 510(k) clearance K150163 for Otowave 202 Portable Tympanometer, Substantially Equivalent on 2015-04-23. Applicant: Amplivox, Ltd.. Device class: 2.

Clearance details

Applicant: Amplivox, Ltd.
Product code: Code NAS
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2015-01-26
Decision date: 2015-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eynsham, GB

Download summary PDF View on FDA.gov ↗

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